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Status unknownNCT01125306Updated Mar 16, 2012

Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

A Phase 4 interventional study of Xal-Ease in Glaucoma and Hypertension, sponsored by Meir Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.

Sponsored by Meir Medical Center · Phase 4, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation.

Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.

02

Conditions studied

  • Glaucoma
  • Hypertension

Keywords

  • Drug consumption
  • The Xal-Ease device
  • Patient's compliance
  • Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Meir Medical Center is the lead sponsor of 389 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years,
  • Patients with severe manual disabilities,
  • Patients with impaired cognition and mentality.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • DeviceXal-Ease

    Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.

    Also known as: Xal-Ease as a Pfizer-Pharmacia device.

06

What researchers measure

Primary outcomes

  1. Consumption of Xalatan/Xalacom bottles per year per patient.

    Time frame: 12 months.

Secondary outcomes

  1. Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease

    Time frame: 12 months

  2. Characterizing the optimal conditions for proper usage of the Xal-Ease device

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • Ophthalmology department, Meir Medical Center
    Kfar-Saba, 44281, Israel
    Recruiting
08

References and documents

Publications

  • Semes L, Shaikh AS. Evaluation of the Xal-Ease latanoprost delivery system. Optometry. 2007 Jan;78(1):30-3. doi: 10.1016/j.optm.2006.06.016. PubMed 17208672 ↗
  • Nordmann JP, Baudouin C, Bron A, Denis P, Rouland JF, Sellem E, Renard JP. Xal-Ease: impact of an ocular hypotensive delivery device on ease of eyedrop administration, patient compliance, and satisfaction. Eur J Ophthalmol. 2009 Nov-Dec;19(6):949-56. doi: 10.1177/112067210901900609. PubMed 19882583 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01125306
Lead sponsor
Meir Medical Center
Responsible party
Sponsor
First posted
May 18, 2010
Start date
Jun 2009
Primary completion
Aug 2011
Completion
Oct 2012 (estimated)
Last update
Mar 16, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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